OncoMatch/Clinical Trials/NCT05407441
Tazemetostat+Nivo/Ipi in INI1-Neg/SMARCA4-Def Tumors
Is NCT05407441 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Tazemetostat and Nivolumab for atypical teratoid rhabdoid tumor.
Treatment: Tazemetostat · Nivolumab · Ipilimumab — This research study involves a combination of three drugs given together as a possible treatment for malignant rhabdoid tumor, atypical teratoid rhabdoid tumor, epithelioid sarcoma, chordoma or other tumors that are deficient in one of two possible proteins, either INI-1 (SMARCB1) or SMARCA4. The names of the study drugs involved in this study are: * Tazemetostat (TAZVERIK) * Nivolumab (OPDIVO) * Ipilimumab (YERVOY)
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Tumor Agnostic
Sarcoma
Biomarker criteria
Required: SMARCB1 loss
Loss of INI1 confirmed by immunohistochemistry (IHC)
Required: SMARCB1 bi-allelic loss
molecular confirmation of tumor bi-allelic SMARCB1 (INI1) loss or mutation when INI1 IHC is equivocal or unavailable
Required: SMARCB1 mutation
molecular confirmation of tumor bi-allelic SMARCB1 (INI1) loss or mutation when INI1 IHC is equivocal or unavailable
Required: SMARCA4 loss
Loss of SMARCA4 confirmed by IHC
Required: SMARCA4 loss
molecular confirmation of tumor SMARCA4 loss or mutation
Required: SMARCA4 mutation
molecular confirmation of tumor SMARCA4 loss or mutation
Prior therapy
Cannot have received: EZH2 inhibitor (tazemetostat)
Exception: Subjects with relapsed/refractory disease (strata A2 and B2) may have received prior single agent tazemetostat or other EZH2 inhibitors for up to 1 year, but subjects without prior progression/relapse may NOT have received any prior EZH2 inhibitors.
Prior EZH2 inhibitor therapy: Subjects with relapsed/refractory disease (strata A2 and B2) may have received prior single agent tazemetostat or other EZH2 inhibitors for up to 1 year, but subjects without prior progression/relapse may NOT have received any prior EZH2 inhibitors.
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant is not allowable.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX40, CD137).
Cannot have received: anti-PD-L1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX40, CD137).
Cannot have received: anti-PD-L2 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX40, CD137).
Cannot have received: anti-CTLA-4 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX40, CD137).
Cannot have received: other T-cell co-inhibitory/stimulatory receptor agent
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. OX40, CD137).
Lab requirements
Blood counts
Absolute neutrophil count ≥1,000/uL; Hemoglobin ≥8 g/dL (may receive RBC transfusions); Platelets: For non-relapsed subjects (Strata A1, A3, B1 or B3): >75K/uL, For subjects with relapsed disease (Strata A2 or B2): >50K/uL, For all subjects: must be platelet transfusion independent, defined as not receiving a platelet transfusion for at least 7 days prior to CBC documenting eligibility.
Kidney function
A serum creatinine based on age/gender as specified OR creatinine clearance ≥ 70 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal for age. ALT (SGPT) and AST (SGOT) ≤ 3 x upper limit of normal (for the purpose of this study, the ULN for ALT is 45 U/L)
Subjects must have adequate organ function as defined below: Bone Marrow Function, Hepatic Function, Renal Function, Pulmonary Function, Neurologic Function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Boston Children's Hospital · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Texas Children's Hospital · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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